Table of Contents
Schedule to the drugs and cosmetics Act 1940
The Schedule to the Drugs and Cosmetics Act 1940 plays a crucial role in regulating the manufacturing, distribution, and sale of drugs and cosmetics in India. It serves as a comprehensive reference guide that outlines the categories, definitions, standards, and specifications of various drugs and cosmetics covered under the Act.
The Schedule provides a detailed classification of drugs based on their potency, therapeutic value, toxicity level, and usage. It categorizes them into different schedules such as Schedule H, Schedule G, Schedule X, etc., each having its own set of regulations regarding procurement, storage, labeling, packaging, and dispensing.
These are two schedules to the act which give the following information:
First schedule:- This includes the name of books under Ayurvedic, Siddha, Unani and Tibb system.
Second schedule:- This includes the standard to be complied by drugs imported and manufactured for sale, sold, sucked, exhibited for sale or distributed.
The following appendix are also included:
Appendix-1
Data to be submitted along with the application for permission to market a new drug.
Appendix-2
Format for submission of clinical trial reports.
Appendix-3
It is required for animal clinical trials and marketing a new drug.
Appendix-4
Number of animals for long term toxicity studies.
Appendix-5
Patient consent from for participation in phase-1 clinical trials.
Appendix-6
Four group of fixed dose combinations and their data requirement.
Legal definition of schedules to rules
Schedule-A
This schedule contains various forms and formats of letter for applications of licensing etc.
Schedule-B
This schedule contains fees structure for government run labs.
Schedule-C
This schedule contains various biological product and their regulation.
Schedule-C1
This schedule contains other special products whose regulation are governed by special provision (non-parenteral administration).
Schedule-D
This schedule contains list of drugs exempted from the provision of import of drugs.
Schedule-E1
This schedule contains various poisonous substance under the Ayurvedic, Siddha and Unani systems of medicines.
Schedule-F
This contains regulation and standard for running a blood bank.
Schedule-F1
This contains regulation and standard for vaccines.
Schedule-F2
This contains regulation and standard for surgical dressing.
Schedule-F3
This contains regulation and standard for umbilical tapes.
Schedule-ff
This schedule contains regulation and standard for ophthalmic preparations.
Schedule-G
This schedule contains those substances which can be used only under medical supervision and which are to be labelled accordingly. Example: Hormonal preparation, Test lactose etc.
Schedule-H
This schedule contains prescription drugs (not to be sold by retail without the prescription of a registered medical practitioner).
Schedule-HX
This schedule for reduce the misuse of antibiotics & other drugs.
Schedule-I
This schedule contains a list of various disease F conditions that cannot be treated under any drug currently in market.
Schedule-K
In this schedule list of drugs exempted from the provision of the manufacture of drugs.
Schedule-M
In this schedule good manufacturing process (GMP) requirements of factory premises, plants and equipment.
Schedule-M1
In this schedule, requirement of factory premises for manufacture of homeopathic preparation.
Schedule-M2
In this schedule, requirement of factory premises for the manufacture of cosmetics.
Schedule-M3
In this schedule, requirement of factory premises for the manufacture of medical devices.
Schedule-N
This schedule contains list of minimum equipment for efficient running of a pharmacy.
Schedule-O
This schedule contains various standard for disinfectant fluids.
Schedule-P
This schedule contains regulation regarding life periods of drugs.
Schedule-P1
This schedule contains regulation regarding package size of drugs.
Schedule-Q
This schedule contains a list of permitted dyes, pigments and colours in soap and cosmetics.
Schedule-R
This schedule contains various regulation and requirement for condoms and other mechanical contracepts.
Schedule-R1
This schedule contains list of standards for medical devices.
Schedule-S
This schedule contains list of standards for cosmetics.
Schedule-T
This schedule contains various regulation and requirement for manufacture of Ayurvedic, Siddha and Unani products.
Schedule-U
This schedule contains various regulation and requirement for record keeping.
Schedule-V
This schedule contains standard for patent or proprietary medicines.
Schedule-W
This schedule contains list of drugs to be marketed under generic names only.
Schedule-X
This schedule contains list of drugs whose import, sale, labelling and packaging are governed by special provision.
Schedule-Y
This schedule contains requirements and guidelines on clinical trials for import and manufacture of new drugs.